| CTRI Number |
CTRI/2025/01/079469 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of SMS on Glaucoma Follow Up |
|
Scientific Title of Study
|
Enhancing Glaucoma Follow Up Using an Automated Short Message System (SMS) in South India |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Upadhyaya |
| Designation |
Glaucoma Consultant |
| Affiliation |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology |
| Address |
Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Upadhyaya |
| Designation |
Glaucoma Consultant |
| Affiliation |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, |
| Address |
B- 21, Staff Quarters, Aravind Eye hospital campus, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Swati Upadhyaya |
| Designation |
Glaucoma Consultant |
| Affiliation |
Glaucoma Services, Aravind Eye Hospital, Pondicherry |
| Address |
Aravind Eye Hospital, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Pondicherry, India. Pin 605007 |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology |
| Address |
Thavalakuppam,
Cuddalore Main Road,Pondicherry.India. 605007 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swati Upadhyaya |
Aravind Eye Hospital, Pondicherry |
Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Thavalakuppam, Pondicherry. Pin 605007
Pondicherry
PONDICHERRY |
8489810704
swati.dr@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AEH-P |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, (2) ICD-10 Condition: H408||Other glaucoma, (3) ICD-10 Condition: H402||Primary angle-closure glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No SMS |
In the control group, no text message will be sent and patients follow up will be monitored |
| Intervention |
Text Message |
The newly diagnosed routine glaucoma study group will receive an SMS text reminder one week before and one day before their follow up appointment which will provide the day and time and location of their follow up appointment. The newly diagnosed high risk glaucoma group will receive a text message reminder every two days during the first week due to the critical need for follow up for these patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 to 75 years diagnosed with glaucoma being seen at the glaucoma clinic at the Aravind Eye Hospital.
2. Newly diagnosed with glaucoma (either routine or high risk), including both primary and secondary glaucoma
3. Anticipate attending all follow-up glaucoma visits at the Aravind Eye Hospital, Pondicherry.
4. Possess a mobile phone or have a caretaker that possesses a mobile phone
a. Able to use texting feature
5. Able to read and understand Tamil
6. Able to provide informed consent.
7. Willingness to receive automated appointment reminders and adhere to study procedures and follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1. Individuals who have undergone intraocular surgery within the last 3 months or who are expected to undergo surgery within the next 1 month (for high risk patients) or within the upcoming 6 months (for routine patients)
a. If the patient undergoes surgery during the study, the patient will be excluded from the study
2. Individuals with other ocular comorbidities that require follow up visits that would occur during the duration of the study
3. Individuals with cognitive impairments interfering with informed consent.
4. Individuals without access to a mobile phone and ability to receive texts
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of the automated SMS messaging system on glaucoma appointment attendance |
1 week, 1 month,3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluate the association of demographics, socioeconomic status, glaucoma severity, and baseline ophthalmic features (IOP, cup-to-disc ratio), ocular and surgical history, and complexity of medication regimens with follow up
2. Assess the utility and acceptability of SMS reminders
3. Survey patients on follow up adherence and barriers to follow up
|
1 week, 1 month,3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study aims to demonstrate that an automated SMS messaging system can significantly enhance follow up adherence among glaucoma patients. We hypothesize that the SMS reminder system will lead to a 20% increase in follow up appointment attendance adherence. Improved adherence is expected to lead to better disease management, fewer complications, and ultimately, better preservation of vision. |